FDA 510(k)
FDA class 2
Substantially Equivalent
🇪🇸 Spain
A1AT Genotyping Test
K Number: K192858
·
Decision Nov 5, 2019
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
2
Applicant Total
4
Review Days
32
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Basic Information
- Device Name
- A1AT Genotyping Test
- K Number
- K192858
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 866.5130
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Progenika Biopharma S.A., A Grifols Company
- Date Received
- October 4, 2019
- Decision Date
- November 5, 2019
- Product Code
- PZH
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PZH | Serpina1 Variant Detection System | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PZH), ordered by most recent decision date.
A1AT Genotyping Test
FDA 510(k)
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A1AT Genotyping Test
FDA 510(k)
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